Patient interface and aspects thereof

ABSTRACT

A patient interface can have a frame supporting a sealing member. Various features of the sealing member can improve comfort and sealing performance in the context of forming seals with the nares of a user, as well as contact with other facial surfaces. The sealing member can include convex portions, concave portions and thickness variations for providing various sealing, comfort, and deformability effects.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference herein in theirentireties and made a part of the present disclosure. The presentapplication claims the priority benefit of U.S. Provisional ApplicationNos. 62/139,562, filed Mar. 27, 2015, and 62/261,177, filed Nov. 30,2015, the entirety of each of which is hereby incorporated by referenceherein.

BACKGROUND Field

The disclosure herein generally relate to interfaces for providing asupply of breathable gas to a recipient.

Description of Related Art

Breathing gases can be delivered to users with a variety of differentmask styles and can be delivered for a variety of different purposes.For example, users can be ventilated using non-invasive ventilation(NIV). In addition, continuous positive airway pressure (CPAP) orvariable airway pressure can be delivered using masks to treat a medicaldisorder, such as obstructive sleep apnea (OSA), chronic obstructivepulmonary disease (COPD), or congestive heart failure (CHF).

These non-invasive ventilation and pressure support therapies generallyinvolve the placement of a user interface device, which is typically anasal or nasal/oral mask, on the face of a user. The flow of breathinggas can be delivered from the pressure/flow generating device to theairway of the user through the mask.

Typically, patient interface devices include a mask frame that supportsa sealing member. The sealing member contacts the facial surfaces of theuser, including regions surrounding the nose, including the nose and thenares. Because such masks are typically worn for an extended period oftime, a variety of concerns must be taken into consideration. Forexample, in providing CPAP to treat OSA, the user normally wears themask all night long while he or she sleeps. One concern in such asituation is that the mask should be as comfortable as possible. It isalso important that the mask provide a sufficient seal against a user'sface without significant discomfort.

SUMMARY

Accordingly, it is an object of certain embodiments of the presentdisclosure to provide an improved sealing member for use in a maskassembly that overcomes the shortcomings of conventional sealingmembers.

In some configurations, a nasal seal includes a seal body formed of asoft flexible material and having a sidewall that at least partiallydefines an inner cavity. The seal body comprises a sealing portionhaving a first nostril prong and a second nostril prong. A base portionof the seal body defines a supply opening that allows a supply ofbreathing gases to be provided to the inner cavity. A bellows portion isdefined by the sidewall. The bellows portion is located between thesealing portion and the supply opening. The bellows portion comprises anindentation that extends circumferentially around the seal body andsupports both the first nostril prong and the second nostril prong.

In some configurations, the indentation has a curved shape incross-section.

In some configurations, the indentation extends around an entirecircumference of the seal body.

In some configurations, the indentation is concave and defined between aconvex base portion of the seal body and a convex sealing portion of theseal body. The convex base portion extends between the indentation andthe supply opening and the convex sealing portion extending between theindentation and the first and second nostril prongs.

In some configurations, the bellows portion is configured to allow forlinear compression and/or expansion of the seal body in an axialdirection along an axis extending through a center of the supply openingand between the first and second nostril prongs.

In some configurations, the bellows portion allows the prongs to pivotsuch that an angle of the prongs relative to the supply opening canvary.

In some configurations, a volume of a portion of the inner cavitydefined by the base portion is less than a volume of a portion of theinner cavity defined by the sealing portion.

In some configurations, a curvature of the bellows portion correspondsto a curvature of a lower surface of the sealing portion adjacent theindentation, and wherein a distance between the bellows portion and thelower surface of the sealing portion is substantially constant around acircumference of the seal body.

In some configurations, a thickness of the bellows portion issubstantially constant throughout the bellows portion.

In some configurations, the sealing portion comprises a pair thickenedregions, each associated with one of the first nostril prong and thesecond nostril prong.

In some configurations, the seal body comprises a thickened portionsurrounding the supply opening.

In some configurations, a middle section of the bellows portion isthinner than a section of the bellows portion adjacent the supplyopening and a section of the bellows portion closest to the first andsecond nostril prongs.

In some configurations, the supply opening is generally elliptical and athickened portion that extends around and defines the supply opening isgenerally elliptical.

In some configurations, a nasal seal includes a seal body formed of asoft flexible material and defines an inner cavity and a supply openingfor supply of breathing gases to the inner cavity. The seal bodycomprises a first nostril prong, a second nostril prong and a rollingsection disposed in a sidewall portion of the seal body. The rollingsection being located between the supply opening and the first andsecond nostril prongs. The rolling section is configured to roll over onitself to reduce a distance between the supply opening and the first andsecond nostril prongs.

In some configurations, the rolling section further comprises a rib thatextends in a circumferential direction of the seal body.

In some configurations, the rib is configured to contact an interiorsurface of the seal body to limit the roll of the rolling section andmaintain the first and second nostril prongs in an operational position.

In some configurations, the rib extends only partially around acircumference of the seal body.

In some configurations, the rib defines a gap in the front of the sealbody.

In some configurations, the gap allows the rolling section in the frontof the seal body to roll further towards or over the supply opening thanthe back of the seal.

In some configurations, the rib is disposed between the supply openingand the first and second nostril prongs and projects inwardly oroutwardly from the sidewall portion.

In some configurations, the rib is positioned halfway between sealingsurfaces of the first and second nostril prongs and the supply opening.

In some configurations, a thickness of the rolling section graduallyvaries between the rib and the supply opening, the rolling portion beingthicker adjacent the rib and thinner adjacent the supply opening.

In some configurations, the rib is cantilevered from the sidewallportion, the rib tapering in thickness between a thicker portionadjacent the sidewall portion and a thinner portion further from thesidewall portion.

In some configurations, the supply opening is kidney bean shaped andgenerally follows the overall shape of the seal body.

In some configurations, an intersection between the rolling section andan end of the seal body that defines the supply opening is curved in alateral direction of the nasal seal.

In some configurations, a nasal seal includes a seal body formed of asoft flexible material and defining an inner cavity that receives asupply of breathing gases. The seal body comprises a first nostril prongand a second nostril prong. Each of the first and second nostril prongsare non-conical and asymmetrical.

In some configurations, the seal body defines a supply opening throughwhich the supply of breathing gases passes into the inner cavity,wherein the supply opening is non-circular in shape.

In some configurations, the supply opening is bean-shaped.

In some configurations, each of the first and second nostril prongscomprises a medial portion, wherein the medial portion is oriented at anangle relative to a central plane of the seal body.

In some configurations, the medial portion comprises an upper portionand a lower portion, wherein the angle relative to the central plane ofthe lower portion is greater than the angle relative to the centralplane of the upper portion.

In some configurations, a rolling portion is defined by a sidewallportion of the seal body and configured to roll over on itself, therolling portion comprising an upper portion configured to be distal ofan upper lip of a user and a lower portion configured to be proximatethe upper lip of the user. The upper portion provides less resistance toroll than the lower portion.

In some configurations, a proximal wall of the seal body comprises aconcave portion extending in a lateral direction of the seal body andhaving a shape that generally conforms to a shape of an upper lip of auser.

In some configurations, the first nostril prong comprises a firstsealing surface and the second nostril prong comprises a second sealingsurface, wherein portions of the first and second sealing surfaces areconvex.

In some configurations, the seal body comprises a central wall portionextending between and connecting the first nostril prong and the secondnostril prong, wherein the central wall portion is spaced deeply from anend surface of the first and second nostril prongs such that contactbetween the central wall portion and a septum of the user is reduced oreliminated.

Various features, aspects and advantages of the present embodiments canbe implemented in any of a variety of manners. For example, whileseveral embodiments will be described herein, sets or subsets offeatures from any of the embodiments can be used with sets or subsets offeatures from any of the other embodiments.

The term “comprising” is used in the specification and claims, means“consisting at least in part of”. When interpreting a statement in thisspecification and claims that includes “comprising”, features other thanthat or those prefaced by the term may also be present. Related termssuch as “comprise” and “comprises” are to be interpreted in the samemanner.

In this specification where reference has been made to patentspecifications, other external documents, or other sources ofinformation, this is generally for the purpose of providing a contextfor discussing the disclosed features. Unless specifically statedotherwise, reference to such external documents is not to be construedas an admission that such documents, or such sources of information, inany jurisdiction, are prior art, or form part of the common generalknowledge in the art.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentdisclosure are described below with reference to the following drawings.

FIG. 1 is a front, top, and right side perspective view of a patientinterface including a seal, a conduit connector, and a gas supplyconduit, configured in accordance with an embodiment.

FIG. 2 is a side elevational view of the interface of FIG. 1.

FIG. 3 is a view of the interface as viewed along line 3. of FIG. 2.

FIG. 4 is a front, left, and top perspective view of the interface ofFIG. 1.

FIG. 5 is an embodiment of a seal body that can be used with theinterface of FIGS. 1-4, viewed in a direction such as that on by arrow3. in FIG. 2.

FIG. 6 is an enlarged schematic and partial sectional view of nostrilsof a human patient.

FIG. 7 is a sectional view of the seal of FIG. 5 engaged with humannostrils schematically illustrated in FIG. 6.

FIG. 7a is a sectional view of the embodiment of FIG. 7, with certainlines removed.

FIG. 7b this is a schematically diagram illustrating variations indimensions of nares amongst some human populations.

FIG. 7c is a view of the seal of FIG. 5, which schematic indications ofexamples of optional locations of sealing between the seal and the naresof differently-shaped human noses.

FIG. 7d is a top plan view of the seal with the schematic indications ofFIG. 7c .

FIG. 7e is a left side elevational view of the seal with the schematicindications of FIG. 7c .

FIG. 7f is a top, front, and left side perspective view of amodification of the seal of FIG. 5.

FIG. 7g is a sectional view of the seal of FIG. 7f , taken along sectionline 7 g.-7 g.

FIG. 7h is a sectional view of the seal of FIG. 7f , taken along sectionline 7 h.-7 h.

FIG. 8 is a perspective and partial sectional view of the seal of FIG.5.

FIG. 9 is another partial sectional and perspective view of the seal ofFIG. 5.

FIG. 10 is a perspective view of the seal of FIG. 5.

FIG. 11 is a front elevational view of the seal of FIG. 5.

FIG. 12 is a perspective view of a modification of the seal of FIGS.5-11.

FIG. 13 is a side elevational view of the seal of FIG. 12.

FIG. 14 is a sectional view of the seal taken along line 14.-14. of FIG.13.

FIG. 15 is an enlarged view of a portion of the sectional view of FIG.14.

FIG. 16 is a sectional view of the seal taken along line 16.-16. of FIG.13.

FIG. 17 is a top plan view of seal of FIG. 12.

FIG. 18 is a skewed view of the seal of FIG. 12 as viewed in thedirection of arrow 3. of FIG. 2.

FIG. 19 is a sectional view of the seal taken along line 16-16 of FIG.13 and illustrating a lateral movement.

FIG. 20 is a top, front and left side perspective view of the sealmember of FIG. 12, including shaded contours corresponding to optionalthicknesses.

FIG. 21 is a left side elevational view of the seal with the thicknessshading of FIG. 20.

FIG. 22 is a bottom, rear and left side perspective view of the sealwith the thickness shading of FIG. 20.

FIG. 23 is a rear elevational view of the seal and with the thicknessshading of FIG. 23.

FIG. 24 is a skewed view of the seal of FIG. 12 taken along a directionidentified by arrow 3. of FIG. 2, and including schematic lines andshading as optional boundaries of different portions of the seal.

FIG. 25 is a top plan view of the seal of FIG. 20.

FIG. 26 is a side elevational view of the seal of FIG. 20.

FIG. 27 is a bottom plan view of the seal of FIG. 20.

FIG. 28 is a front elevational view of the seal of FIG. 20.

FIG. 29 is perspective view of the seal of FIG. 20.

FIG. 30 is a rear, right, and bottom perspective view of the seal ofFIG. 20.

FIG. 31 is a perspective view of the seal of FIG. 20.

FIG. 32 is a perspective view of an example embodiment of a sealincluding a bellows.

FIG. 33 is a sectional view of the seal of FIG. 32 showing alongitudinal axis and possible pivoting movement of the seal.

FIG. 34 is a sectional view of the seal of FIG. 32 showing an outline ofa compressed profile of the seal.

FIG. 35 is a force vs. compression graph.

FIG. 36 is a sectional view of the seal of FIG. 32.

FIG. 37 is another sectional view of the seal of FIG. 32.

FIG. 38 is a sectional view of the seal of FIG. 32 showing widths ofvarious parts of the seal.

FIG. 39 is a sectional view of the seal of FIG. 32 showing an outline ofa splayed profile of the seal.

FIG. 40 is sectional view of the seal of FIG. 32 showing an outline ofan inflated profile of the seal.

FIG. 41 is a perspective view of an embodiment of the seal of FIG. 32including a thickened region.

FIG. 42A is a sectional view of the seal of FIG. 32.

FIG. 42B is a view of the seal of FIG. 32 as viewed along line 3. ofFIG. 2.

FIG. 42C is a side elevational view of the seal of FIG. 32.

FIGS. 42D, 42E and 42F show various views of the seal of FIG. 32 showinginterior volumes of various regions of the seal.

FIGS. 42G, 42H and 42I show various views of the seal of FIG. 32 showinginterior volumes of various regions of the seal.

FIG. 43 is a sectional view of an example embodiment of a seal having arolling section.

FIG. 44 is a sectional view of the seal of FIG. 43 showing an outline ofthe rolling section of the seal in a rolled state.

FIG. 45 is a detail view of a portion of a sectional view of the seal ofFIG. 43 showing an internal rib.

FIG. 46 is a detail view of a portion of a sectional view of the seal ofFIG. 43 showing varying thickness in the rolling section.

FIG. 47 is a theoretical force v. displacement profile of the seal ofFIG. 43.

FIG. 48 shows a force profile of the seal of FIG. 43.

FIG. 49 shows a heat map illustrating the thickness of various regionsof the seal of FIG. 43.

FIGS. 50A, 50B and 50C illustrate front elevational views of the seal ofFIG. 43.

FIG. 51 is a sectional view of the seal of FIG. 43 showing a depth ofthe rolling section.

FIG. 52 is a sectional view of the seal of FIG. 43 showing an outline ofthe seal in a splayed state.

FIG. 53A is a top view of the seal of FIG. 43.

FIG. 53B is a detail view of a connector receiving portion of the sealof FIG. 43.

FIGS. 54A, 54B and 54C are various views of the seal of FIG. 43.

DETAILED DESCRIPTION

FIGS. 1-4 schematically illustrate a patient interface 100 that caninclude one or any combination of certain features, aspects, andadvantages described herein. The interface 100 can be used to supplypressurized breathing gases to a recipient, such as a user or a patient.The interface 100 can be used for providing breathing gases to arecipient in situations where significant pressure changes may beencountered. For example but without limitation, the interface 100 canbe used for delivering continuous positive airway pressure (CPAP).

With continued reference to FIGS. 1-4, the patient interface 100 isshown separated from a patient who might wear the interface 100. Someaspects of the patient interface 100, and variations on each aspect,have been described in U.S. patent application Ser. No. 12/945,141,filed Nov. 12, 2010, which is hereby incorporated by reference in itsentirety. The interface 100 can be in the form of a mask 102. In someconfigurations, a strap 104 can be used to secure the mask to a patient.In some configurations, the interface can also comprise a flexiblesupply conduit 106 which can connect to the mask 102.

The mask 102 can be configured to fit over or overlie both nostrils of apatient. The strap 104 can be wrapped around the user's head in a simpleloop above the user's ears, although other configurations and uses forthe strap 104 are also available. In some configurations, the mask 102can include lateral extending portions (not shown) configured to curvearound toward each lateral side of a nose of a patient. Such lateralportions can form a perimeter seal on outwardly facing surfaces offlanks of the nose. On the other hand, the embodiments disclosed hereinare described in the context of masks, which can be referred to as nasalpillow masks, which do not include laterally extending portionsconfigured to curve around toward each lateral side of the nose of apatient to contact or form a perimeter seal on outwardly facing surfacesof flanks of the nose of a patient, such as the wings 130 disclosed inPCT Application No. PCT/NZ2014/000150 filed Jul. 17, 2014. Some of theembodiments disclosed herein can provide beneficial advantages ofenhanced seals sealing performance and comfort while eliminating suchlaterally extending portions.

The flexible conduit 106 can depend from a central connection 112. Insome configurations, the central connection 112 can be positioned at afrontal portion of the mask 102. The central connection 112 can includea swiveling elbow. Such a swiveling elbow can be configured to allow theflexible conduit 106 to pivot relative to the mask 102. By enablingpivoting, the elbow can help the interface 100 to better adapt to thesleeping positions of a patient. In some configurations, the centralconnection 112 may comprise a ball joint so that the elbow can pivotabout axes parallel to and perpendicular to its connection with the mask102. In some configurations, the central connection 112 may comprise aswivel or swivel elbow.

The illustrated mask 102 can generally comprise a seal 114 and a body orframe 116. The seal 114 and the frame 116 can be connected in anysuitable manner.

The seal 114 can define a supple pocket or envelope that can contain arecess region. In some configurations, the seal 114 can comprise a lowwall thickness and can be formed of any suitable material. For examplebut without limitation, the seal 114 can be formed of latex, vinyl,silicone or polyurethane. In some configurations the wall thickness canbe below about 0.5 millimeters and could be lower than about 0.2millimeters in some regions and in some configurations. Additionally, asdescribed below, some portions of the seal 114 can include thickenedregions having thicknesses of 0.7 millimeters, 0.9 millimeters, 1.2millimeters, as well as greater thicknesses. In some configurations, theseal 114 can be formed of a material having sufficient elasticity andyield strength so that the combination renders the seal 114 supple. Theseal 114 can be configured to withstand repeated drastic deformationswithout failure.

With continued reference to FIGS. 1-4, the seal 114 can include one ortwo nostril prongs 120, 121. The nostril locators 120, 121, can protrudefrom the seal 114. In some configurations, the nostril locators 120, 121extend generally upwardly and rearwardly from a proximal wall 124 of theseal 114. As used herein, the term “proximal” is intended to refer toportions of the mask 102 that are proximate or closer to a patientduring use. On the other hand, the term “distal” is used to refer toportions of the mask 102 which are disposed further away from a patientduring use.

In the configurations illustrated in FIGS. 1-4, the nostril prongs 120,121 are formed integrally (i.e., in a single monolithic piece) with theseal 114. Each nostril prong 120, 121 can comprise an outward aperture118, 119 through which gas can be supplied from the flexible conduit106, to nostrils of the patient. In some configurations, the gas can besupplied from within the pocket or envelope defined by the seal 114. Inother configurations, the gas that is supplied can be separate from thegas supplied to the pocket or envelop defined by the seal 114.

The seal 114 can also be considered as having a distal wall 122. Assuch, an outer surface of the distal wall 122 would face away from theuser during use, while an outer surface of the proximal wall 124 wouldface the user.

The seal 114 can also include left and right lateral walls 125, 126disposed on the left and right sides, respectively, of the nostrilprongs 120, 121. Additionally, the seal 114 can include an intermediatewall portion 127 extending between the nostril prongs 120, 121. Thewalls 122, 124, 125, 126 extend from the nostril prongs 120, 121 towardthe flexible conduit 106, along the direction of arrow A in FIG. 2.Thus, proximal portions of the walls 122, 124, 125, 126 can beconsidered as connecting with the nostril prongs 120, 121. Distal endsof the walls 122, 124, 125, 126 can extend to an inlet orifice 130 (FIG.7). The inlet orifice 130 can be connected to the frame 116 and/ordirectly to the flexible conduit 106.

As such, the envelope or pocket described above can be defined within atleast the distal wall 122 and the proximal wall 124 and/or optionally,the lateral walls 125, 126, or a combination thereof. The seal 114 canbe configured to achieve a desired seal without wrapping around the tipor lower portion (e.g., locations below the bridge) onto substantialportions of the outer surfaces a user's nose. However, in someembodiments, the seal 114 can be designed to wrap around the tip orlower portion of a user's nose. The seal 114 can also be considered asincluding a central portion 128 which can be considered as including thenostril prongs 120, 121, and the central wall 127. The central portion128 can, in some embodiments, include sealing surfaces of the mask 102which form seals with the nostrils of a user during use. The centralwall 127 can be disposed significantly deeper and further distally fromthe orifices 118, 119 than the other portions, such as the sealingsurface within the central portion 128. As such, the central wall 127provides improved clearance for the user's septum, reducing contact andpotential discomfort or irritation.

As described above, optionally, a substantial portion of the seal 114can be supple. For example, a region surrounding the nostril locators,such as the central region 128, can be more supple than distal portionsof the walls 122, 124, 125, 126. Further, optionally, the proximal wall124 and the nostril prongs 120, 121 can be very supple so that they canexpand to conform to the contours of a user's nares. The supple portionsof the seal 114 can be of sufficient dimension and shape that whenpositive pressure of gases within the seal 114 can partially expandportions of the seal 114 to enhance a seal between the seal 114 and theuser's face, for example, nostrils of the user. Additionally, portionsof the seal, for example, along proximal portions of the proximal wall124 can rest against or provide the sealing engagement with a portion ofthe user's upper lip.

Optionally, portions of the seal 114 can have an increased rigidity toimprove form, fit, and function of the mask 102. For example, portionsof the seal 114 can be made significantly stiffer to provide control ofballooning of other regions of the seal 114. Further, distal portions ofthe walls 122, 124, 125, 126, for example, regions or areas adjacent toor proximate to the inlet orifice 130 (FIG. 7) can be less supple. Thus,for example, one or more the walls 122, 124, 125, 126 can have adecreasing suppleness from the proximal portions thereof to the distalportions thereof. Such less supple regions can be formed of a differentmaterial or can be formed of the same material but with an increasedthickness.

The frame 116 can have any arrangement for fixation or connection to theseal 114. In some configurations, an annular wall can extend from aproximal side of the frame 116 around a perimeter of an openingextending to the connector 112. The annular wall can include anoutwardly extending lip. The inlet orifice 130 of the seal 114 canengage over the outwardly extending lip of the annular wall. In someconfigurations, the inlet orifice 130 of the seal 114 can be stretchedto fit over the annular wall. The inlet orifice 130 of the seal 114 canbe provided with a thickened or reinforced wall section, for example butwith limitation. In some configurations, an extended portion of theinlet orifice 130 can be rolled up over the annular wall of the frame116. In other configurations, the seal 114 can be provided with aportion of a connector on at least one of the frame 116 and the conduit106 can include a complimentary connector portion.

The frame 116 can be configured to be minimal in size. For example, asmall sized frame 116 can enable a clear field of vision for the userand can allow a user to wear glasses while wearing the interface 100.The frame 116 can be formed of an elastomeric material, which can allowthe frame 116 to flex to conform slightly to the face of the user. Theframe 116, however, can provide some support for the seal 114. Byproviding support for the seal 114, the seal 114 can be more effectivelypressed into contact with the face and nose of the user. The frame 116can be formed by injection molding, preferably from an elastic material,such as silicone or polyurethane, for example but without limitation. Insome configurations, the frame 116 can be formed of more rigidmaterials, such as polycarbonate, polyester polystyrene, or nylon, forexample but without limitation.

In use, portions of the seal 114 can be inflated and thus expandedoutwardly. Pressure within the seal 114 (e.g., inflated from the flow ofpressurized gases supplied to the patient interface 100) can press thesealing surfaces of the seal 114 against the skin of a user and tofurther conform to contours of the outside surfaces of the nose of theuser, to surfaces of the lower portion of the nose of the user, tovarious portions of the nares of the user, as well as surfaces of theupper lip of the user immediately below the nose.

With reference to FIG. 6, the lower portion of a human nose 200(illustrated in front elevation and partial cross section) can beconsidered as including the walls and surfaces and portions describedbelow, the names of which are included herein for facilitatingunderstanding of the present disclosure.

With continued reference to FIG. 6, the lower end of a human nose 200can include a right nostril lateral wall 202, a left nostril lateralwall 204, and a septum 206. The right nostril lateral wall 202 extendsfrom a forward facing surface of the patient's face, to the tip of thenose. Similarly, the left nostril lateral wall 204 extends from a leftside of the user's face toward the tip of the nose. The septum 206extends from the user's face to the tip of the nose, and between theleft and right nostril lateral walls 202, 204. As such, the rightnostril lateral wall 202 and the septum 206 define the right nostril 208of the user. Similarly, the left nostril lateral wall 204 and the septum206 define the right nostril 210 of the user.

The lower ends of the lateral walls 202, 204 and the septum 206 can bealso considered as forming the nares of the user, including outer, innerand lower surfaces thereof.

For example, the lower portion of the right nostril lateral wall 202 canbe considered as having lateral outer surface 212, bottom surface 214,and intermedial surface 216. Similarly, the lower portion of the leftnostril lateral wall 204 can be considered as including outer lateralsurface 218, bottom surface 220, and intermedial surface 222.

The septum 206 can be considered as including right lateral surface 224,bottom surface 226 and left lateral surface 228.

With reference to FIG. 5, the right and left nostril prongs 120, 121 canalso be considered as including lateral, medial, proximal, and distalportions. For example, the right nostril prong 120 can be considered asincluding a proximal portion 240, a lateral portion 242, a distalportion 244 and a medial portion 246. Similarly, the left nostril prong121 can be considered as including a proximal portion 250, a lateralportion 252, a distal portion 254 and a medial portion 256.

With continued reference to FIG. 7, as noted above, the seal 114 can beconfigured to be sufficiently supple that it can be inflated and thusexpanded by positive pressure within the seal 114. Thus, for example, asillustrated in FIG. 7, such pressure can beneficially push the lateralportions 242, 252 of the right and left nostril prongs 120, 121 intoenhanced contact with the medial surfaces 216, 222, and optionallyfurther contact with the bottom surfaces 214, 220, and furtheroptionally, the lateral surfaces 212, 218, optionally without makingcontact with substantial portions of the lateral surfaces 212, 218.Similarly, the medial portions 246, 256 can be pushed inwardly by thepositive pressure, thereby increasing contact and sealing effect againstthe lateral walls 224, 228.

With continued reference to FIGS. 7 and 7 a, as described above, thenostril prongs 120, 121 can be configured to seal against the septum 206and the lateral nostril walls 202, 204, differently. For example, asdescribed above, the medial portions 246, 256 of the nostril prongs 120,121 can be configured, oriented, and/or shaped to press more against thelateral surfaces 220 a, 224 of the septum 206 and reduce or minimizecontact with bottom surface 226 of the septum 206. Optionally, thecentral wall 127, as noted above, can be spaced deeply between thenostril prongs 120, 121, so as to reduced or eliminate the likelihood ofcontact with any or a substantial portion of the bottom surface 226 ofthe septum 206. The degree to which the medial portions 246, 256 pressagainst the lateral surfaces 224, 228 and less on the bottom surface 226can be contrasted with the configuration, shape, and orientation of thelaterals portions 242 and 252.

Optionally, the lateral portions 242, 252 can be shaped, configuredand/or oriented so as to contact less of the medial portions 216, 222 ofthe right and left nostril walls 202, 204 and more of the bottomsurfaces 214, 220 and the lateral surfaces 212, 218, during use, ascompared with the contact of the medial portions 246, 256 with thecorresponding portions of the septum 206, described above.

Asymmetric Prongs

With reference to FIGS. 7 and 7 a, optionally, in some embodiments, thenostril prongs 120, 121 can be configured to provide a differentialsealing contact with a user's nose 200, with an asymmetric prong shape.Certain aspects of the asymmetry of the prongs 120, 121 can be describedwith reference to a central plane P bisecting the seal 114 in adirection directly between the prongs 120, 121. For example, as shown inFIG. 7a , the medial portion 256 of the nostril prong 121 extends in adirection that is nearly vertical or in other words, parallel, nearlyparallel, substantially parallel, or within approximately 10 degrees ofthe central plane P. In some embodiments, the medial portion 256 ofnostril prong 121 extends at an angle, with respect to central plane P,of approximately 10 degrees, 0-15 degrees, 0-5 degrees, 5-10 degrees,10-15 degrees, 5-15 degrees, greater than 0 degrees, or varioussub-ranges of 0-15 degrees. The slope of the medial portion 256 isrepresented by line 270. With regard to this description of the seal114, and other descriptions set forth below, in some instances, featuresare only described in connection with one of the prongs 120, 121, but itis to be understood that both of the prongs 120, 121 can have the sameshape, and thus the descriptions would apply equally to both prongs 120,121. With continued reference to FIG. 7a , in some embodiments, themedial portion 256 comprises an upper portion 256 a and a lower portion256 b. The upper portion 256 a can be angled, with respect to plane P,at approximately 10 degrees, 0-15 degrees, 0-5 degrees, 5-10 degrees,10-15 degrees, 5-15 degrees, greater than 0 degrees, or varioussub-ranges of 0-15 degrees. The lower portion 256 b of the medialportion 256 can be angled, with respect to plane P, at approximately 20degrees, 0-30 degrees, 0-20 degrees, 10-30 degrees, 15-25 degrees. Insome embodiments, the upper portion 256 a of the medial portion 256comprises up to one half of the medial portion 256.

In contrast to the slope of the medial portion 256, the slope of thelateral portion 252 is not nearly parallel, approximately parallel orsubstantially parallel with the central plane P. Rather, the slope ofthe lateral portion 252 is transverse to the plane P and optionally canbe nearly perpendicular to the plane P. In FIG. 7a , the slope of thelateral portion 252 is identified by the line 272. The line 272 extendsat an angle of about 75 degrees relative to the plane P. In someembodiments, the slope 272 can be within the range of approximately60-90 degrees relative to the plane P. In some embodiments, the angle isapproximately 70 degrees, 60-70 degrees, 70-80 degrees, 80-90 degrees,60-75 degrees, 75-90 degrees, less than 90 degrees, or varioussub-ranges of 60-90 degrees.

With continue reference to FIGS. 5 and 7 a, the difference in shapebetween the medial portions 246, 256 and the lateral portions 242, 252also extends, optionally, partly into the distal and proximal portions244, 254, 240, 250. Additionally, the distal and proximal portions 244,254 can extend through contours so as to smoothly transition between thedifferent shapes of the medial portions 246, 256 and the lateralportions 242, 252. For example, portions of the proximal and distalportions 250, 254 adjacent to the lateral portion 252 can have a similarshape, while portions of the proximal and distal portions 250, 254adjacent to the medial portion 256 can have a shape similar to themedial portion 256, so as to provide a smooth transition around theperiphery of the prongs 120, 121.

Convex Sealing Surface

Optionally, the seal 114 can include further features for sealingdifferently against the left and right lateral walls 202, 204 comparedto sealing against the septum 206. For example, with reference to FIG.7a , as noted above, the medial portions 246, 256 of the prongs 120, 121extend generally vertical or parallel with the central plane P. Incontrast, the lateral portions 242, 252 can include a convex sealingsurface positioned for contact with the lower portion of the patient'slateral nostril walls 202, 204.

As shown in FIG. 7a , a proximal end of the lateral portion 242 includesa concave portion 280. Distal from the portion 280 is a convex portion282. The concave and convex portions 280, 282 fall within the centralarea 128 which can be considered as comprising the sealing surfaces ofthe seal 114, described above with reference to FIG. 3.

In some embodiments, the concave portion 280 can be smaller than theconvex portion 282. Thus, the concave portion may only act as a sealingsurface on patients with particularly small nares. The convex portion282 can be larger to accommodate a larger range of different size nares,and preferentially sealing against such nares with the convex portion282 which is convex in a relaxed state, but may be deformed into aconcave state upon application against a patient's nose 280. In thisrespect, in at least some patients, the concave portion 280 may be alocating or alignment feature and the convex portion 282 is a sealingsurface. Extending in a substantially horizontal angle can help limitthe depth to which the nostril prongs 120, 121 extend into the patient'snostrils 208, 210. Inserting prongs too deeply into a patient's nose cancause contact with sensitive internal surfaces of the nares and causeirritation and discomfort for the patient. Thus, the depth of the prongs120, 121 and the extent to which prongs 120, 121 would extend into anose can be balanced with the need for stability provided by the prongs120, 121, which is enhanced when the prongs 120, 121 sit far enoughwithin the nostrils that they aren't too easily displaced when the mask102 moves on the patient's face. In a non-limiting example, the distancebetween the medial surface 246 and the lateral end of the concaveportion 280 is approximately 12.7 millimeters, and the width of theconvex portion 282 can be approximately 6.8 millimeters, as measured inthe directions identified in FIG. 7a .

As noted above, the prongs 120, 121 and have a concave sealing areawhich can be configured to provide reduced contact area with nares auser, so as to reduce irritation of the nares. Measurements of humannoses have revealed that among at least some groups of humanpopulations, the width x of a human septum 226, is fairly constant,i.e., varies little. On the other hand, such measurements have revealedthat the length y of human nares, as well as the outermost width ofhuman nares, vary relatively more. Thus, the shape of the openings andthe prongs 120, 121 themselves, are generally non-conical and asymmetricso as to better accommodate these variations. For example, as notedabove, because the with x of the human septum 226 varies little, theshape of the prongs 120, 121, in those areas which would contact aseptum 226, such as the medial walls 256, 246, can be fairly vertical soas to reduce the likelihood of irritation caused on the nares, such asthe lateral wall portions 224, 228, and the lower wall of the septum226.

For example, with reference to FIG. 7c , longer and narrower nostrilscan tend to seal around the prong 120 along sealing line 286, smallernostrils can tend to seal around the prong 120 along sealing line 287,and wider nostrils can tend to seal around the prong 120 along sealingline 288. With regard to FIG. 7d , comparison of the lines 286, 287,288, shows a distal-proximal variation Vz (generally corresponding tothe “z” dimension identified above with reference to FIG. 7b ) in thelateral locations of the lines 286, 287, 288, on the lateral portions242, 252, of the prongs 120, 121.

Similarly, with reference to FIG. 7e , comparison of the lines 286, 287,288 shows a medial-lateral variation VY (generally corresponding to the“y” dimension identified above with reference to FIG. 7b ) of thelocations of the feeling lines 286, 287, 288, on the distal portions244, 254, of the prongs 120, 121.

FIGS. 7f-7h illustrate a modification of the seal 114, identifiedgenerally by the reference numeral 114 a that can also include thefeatures described above with reference to seal 114 as well as thefeatures described below with reference to seal 1114.

Semi-Inflating Seal

As noted above, the sealing surfaces extending around the nostril prongs120, 121 can be made sufficiently flexible and supple so as to inflateto a degree when subject to positive air pressure within the seal 114.Such inflation allows for more positive engagement between the sealingsurfaces and the lower surfaces of the patient's nose. Morespecifically, the proximal, lateral, distal, and medial portions 240,242, 244, 246 of the nostril prong 120, which comprise the sealingsurfaces within the area 128, can be made sufficiently thin and/orsupple so as to partially inflate and deflect under positive pressuregenerated within the seal 114. As such, these portions 240, 242, 244,246 can deflect to a degree, i.e., outwardly, so as to provide betterpositive sealing and engagement with the medial surface 228 of theseptum 206 and the medial, bottom, and lateral surfaces 222, 220, 218 ofthe patient's lateral nostril wall 204.

Lip Engagement

Optionally, the seal 114 can also include enhanced comfort and/orengagement with an upper lip of a patient. For example, with referenceto FIG. 5, the proximal wall 124 can include a concave portion 290extending in a lateral direction, transverse to the central plane P.This concave portion 290 can have a shape that generally conforms to atypical shape of a human's upper lip, and particularly the portion ofthe upper lip proximal to the lower end of the user's nose. Typically,the upper lip of a human extends in a lateral direction and has agenerally convex shape. Thus, the concave portion 290 is configured tofit a typical human upper lip configuration. In some embodiments, theconcave portion 290 extends over a distance 292 which is approximatelyequal to a distance between the centers of the nostril prongs 120, 121.However, other lengths of the concave portion can also be used.

In some embodiments, the concave portion 290 includes a radius ofcurvature 291 of approximately 12.5 mm, 10-15 mm, 12-13 mm, or varioussub-ranges thereof. However, other configurations can also be used.Optionally, the thickness of the proximal wall 124, in the area of theconcave portion 290, can be reduced so that it conforms more readily tothe lip geometry of individual users. In a non-limiting exemplaryembodiment, the thickness of the proximal wall 124 is approximately 0.7mm.

Rolling Section

Optionally, the seal 114 can include a configuration for a preferentialrolling deformation in the vicinity of the connection between the sidewalls of the seal 114 and the inlet orifice 130. For example, asdescribed above with reference to FIG. 2, the proximal, lateral, anddistal walls 124, 125, 126, 122, extend from the nostril prongs 120, 121to the inlet orifice 130. The distal ends of the walls 124, 125, 126,122, include rolling portions formed in the vicinity of the inletorifice 130, for example, including the last few millimeters of thewalls. For example, the walls can extend toward the inlet orifice 130along the direction A (FIGS. 2 and 7), overshoot the connection point tothe inlet orifice 130, and curl back, in a direction opposite to thedirection of arrow A. This overshoot and curl configuration generates anarea in these walls which tends to deform first when forces are applied,causing a rolling deformation effect.

With reference to FIG. 11, the rolling portions at the distal ends ofthe walls 122, 124, 125, 126 can be considered as being within the area300. Thus, the walls 122, 124, 125, 126 can have associated rollingportions 302, 304, 306, 308, within the rolling area 300, as illustratedin FIG. 11. The cross-section of FIG. 7 illustrates a configuration ofthe portions 306, 308.

As shown in FIG. 7, the wall 126 extends distally from the nostril prong120 to the rolling portion 306. The rolling portion 306 extends beyondthe connection point 310; i.e., lower than the connection point 310 asviewed in FIG. 7, then extends upwardly in a direction opposite to thedirection of arrow A, to the connection point 310. This overshot andcurled back configuration of the rolling portion 306 can provide forenhanced and preferential deformation and rolling of the rolling area300.

FIG. 9 illustrates rolling portions 302 and 304. As shown in FIG. 9, therolling portion 302 is generally larger than the rolling portion 304.One characteristic of the rolling portion 302 that is larger than therolling portion 304 is the magnitude of the overshoot, identifiedgenerally by the reference numeral 320. As illustrated in FIG. 9, theovershoot 320 is larger than the overshoot 322. In some embodiments, theovershoot 320 can be approximately 1 millimeters and the overshoot 322can be approximately 0.5 millimeters.

Another differentiating characteristic of the rolling portions 302 and304 is the radial dimensions of the rolling portions 302, 304. Forexample, as shown in FIG. 9 the rolling portion 302 has a radialdimension 324 that is larger than a corresponding radial dimension 326of the rolling portion 304. In some embodiments, the radial dimension324 is approximately 8 mm. In some embodiments, the radial dimension 326is approximately 3 mm.

These dimensional differences provide a differential rolling propensityof the rolling portions 302 and 304. For example, the larger overshoot320 and larger radial dimension 324 can cause the rolling portion 302 toroll more readily and through larger magnitudes of rolling deformationthan the rolling portion 304.

As such, although the rolling area 300 can extend around the entireperiphery of the inlet orifice 130, it can be configured to more readilyroll and deform at the distal portions of the seal 114. Thinner wallsections, near the inlet orifice 130, for example, in the rolling area300, can help determine points at which rolling deformation is initiatedor greater in magnitude.

The rolling area 300 can act as a shock absorber that can isolateeffects of hose drag, for example, forces on the conduit 106 and tensionthat may be generated in the head gear or strap 104 (FIG. 1), preventingthose forces or tensions from affecting the seal performance. This canhelp reduce the likelihood that the nostril prongs 120, 121 are pulledaway from the patient's nose 200, thereby preventing or reducing thelikelihood of leaking.

With reference to FIG. 9, during use, the inlet orifice 130 can berelatively close to the upper lip of the user. Thus, lower portions ofthe frame 116 and connector 112 can also be close to the upper lip ofthe user. Thus, by providing the rolling section 304 with smallerdimensions and or larger thicknesses can provide the optional benefit ofa lower propensity for rolling. Optionally, the rolling portion 304 canbe configured for very little rolling in this area. Such rollingportions 300 can help reduce the likelihood that the seal 114 willcollapse on the patient's lip or other parts of the face, therebyproviding an enhanced degree of stability that helps maintain theposition of the sealing surfaces relative to the lower nasal surfaces ofthe user's nose 200. Optionally, the rolling portion 302 can have acontinuous curve to thereby increase the likelihood that the portion 302will roll rather than collapse or fold during use.

FIGS. 12-31 illustrate a modification of the seal 114, identifiedgenerally by the reference numeral 1114. Parts, components, and featuresof the seal 1114 which are similar or the same as corresponding parts,components, or features of the seal 114 are identified with the samereference numeral, except that 1000 has been added thereto.

With reference to FIGS. 12-19, the seal 1114 can include the samefeatures of the seal 114 noted above with respect to asymmetric prongs,convex sealing surfaces, semi-inflating, lip engagement, and rolling.Thus, those features which can optionally be embodied in the seal 1114,are not further described below.

The seal 1114 includes an optional configuration for enhancing responseto lateral forces and a rolling movement accommodated by the lateralwalls 1125, 1126.

With reference to FIG. 16, the lateral wall 1125 can be considered asextending from the nostril prong 120, in the direction of arrow A,toward the inlet orifice 1130. The seal 1114 can optionally include therolling portion 306 in the area proximal to the inlet orifice 1130.Additionally, the seal 1114 can include an additional rolling portion1400 in the lateral wall 1125. The seal 1114 can include an additionalrolling portion 1400 in the lateral wall 1126. For brevity, thedescription set forth below of the rolling portion 1400 only withreference to the lateral wall 1125, however, this description alsoapplies equally to the lateral wall 1126.

With reference to FIG. 19, as noted above with reference to the seal 114and FIG. 7a , the medial portion 1256 comprises an upper portion 1256 aand a lower portion 1256 b. The upper portion 1256 a can be angled, withrespect to plane P, at approximately 10 degrees, 0-15 degrees, 0-5degrees, 5-10 degrees, 10-15 degrees, 5-15 degrees, greater than 0degrees, or various sub-ranges of 0-15 degrees. The lower portion 1256 bof the medial portion 1256 can be angled, with respect to plane P, atapproximately 20 degrees, 0-30 degrees, 0-20 degrees, 10-30 degrees,15-25 degrees. In some embodiments, the upper portion 1256 a of themedial portion 1256 comprises up to one half of the medial portion 1256.

As viewed in the cross-section of FIG. 16, the rolling portion 1400 cancomprise a concave portion of the lateral wall 1125. With reference toFIG. 12, the concave portion 1400 can extend across the lateral wall1125, in the circumferential direction around the seal 1114. Optionally,portions of the concave portion 1400 can extend onto portions of thedistal wall 1122 and the proximal wall 1124. As noted above, the lateral1126 can include the same or similar concave portion 1400.

By including a concave portion 1400 along the lateral wall 1125, betweenthe nostril prong 120 and the rolling portion 306, the concave portion1400 can help facilitate a more dispersed and larger magnitude rollingdeformations. For example, with reference to FIG. 19, when a user iswearing a mask including the seal 1114, a lateral force F can causedeformation of the seal 1114. The force F can be caused by numerousdifferent sources. For example, the force F can be generated when a usersleeps on their side with the side of their head resting on a pillow. Insuch as position, the pillow can push on a side of the seal 1114, frame116 or the conduit 106. The force F can be caused in other ways as well.

In response to the force F, the seal 1114 can deform, for example, theinlet orifice 1130 can be pushed laterally towards the right, as viewedin FIG. 19, causing the side wall 1126 to deform, allowing the inletorifice 1130 to move laterally relative to the nostril prongs 120, 121.This is also known as a “racking” motion. The concave portions 1400 canhelp allow the side walls 1125, 1126 to rack in response to the force Fand thus more readily allow the motion to be accommodated withoutcollapsing the seal 1114. In addition to “racking” motion, there may besome rolling or rotating (not shown) of the inlet orifice 1130 inresponse to the force F.

With reference to FIGS. 14 and 15, the seal 1114 can also include athickened area 1410. As shown in FIG. 14, the thickened area 1410 can beapproximately centered in the lateral walls 125, 126. Thus, as shown inthe sectional view of FIG. 14, as the lateral wall 126 extends from theproximal wall 1124 toward the distal wall 1122, the thickness of thelateral wall 1126 starts from a thinner thickness adjacent to theproximal wall 1124, thickens in the thickened portion 1410, then reducesthickness again in the portions approaching the distal wall 1122. Insome embodiments, the portions adjacent to the proximal wall 1124 can bein the range of 0.7 to 0.9 millimeters. The thickened portion can have athickness of 1.2 millimeters, and the portions of the lateral wall 1126adjacent the distal wall 1122 can have a thinner thickness, for example,0.7 millimeters. The above mentioned thicknesses are merely example andare not intended to be limiting.

With reference to FIGS. 20-23, the thickened portion 1410 of the seal1114 can be roughly circular and can optionally be disposed within theconcave portion 1400. As shown in the various views of FIGS. 20-23, theareas indicated by shading 1420 can be approximately 0.75 millimeters,the thickness of the region shaded 1422 can be approximately 0.9millimeters, and the thickness of the region shaded 1424 can beapproximately 1.1 millimeters. These thicknesses are merely examples ofan embodiment, and other thicknesses can be used. As shown in FIGS.21-23, additional thickened areas can be disposed near the rollingportion 1300.

The additional rolling structure provided to the lateral walls 1125,1126 can provide for additional comfort and sealing performance. Theconcave portion 1400 and/or the thickened portion 1410 can provide anadditional rolling section that forms a cushion and can act as a shockabsorber, such that movement of the sealing surfaces extending aroundthe nostril prongs 120, 121 and the movements of the frame 116 can bemore isolated from one another. The concave portion 1400 can extend onportions of the seal 1114 forward from the patient's face and on lateralwalls 1125, 1126, as described above.

The concave sections 1400 can be configured to provide more stabilityunder lateral, side-to-side movement of the seal 1114, such as thatillustrated and described above with reference to FIG. 19. An additionalbenefit is that the concave portions 1400 can help reduce the overallvisual appearance of the sides of the seal 1114, improving patientacceptance.

Seal with Bellows

FIGS. 32-42I illustrate an example embodiment of a seal 500 thatincludes a sealing portion 510 and a lower bellows portion 520. Thesealing portion 510 includes nostril prongs 120, 121 and sealingsurfaces 512 that form seals with the nostrils of a user during use,which may be similar to other embodiments shown and described herein.The lower bellows portion 520 supports the sealing portion 510. Thelower bellows portion 520 includes a bellows structure 522 and the inletorifice 130.

The bellows structure 522 extends circumferentially around a portion oran entirety of a base and/or the inlet orifice 130 of the seal 500. Thebellows structure 522 allows for linear compression and/or expansion ofthe seal 500 in an axial direction (e.g., along an axis extendingthrough a center of the inlet orifice 130 and between the prongs 120,121 as shown by the dashed lines in FIG. 33) as shown by outline 524 inFIG. 34. Such compression and/or expansion can advantageously compensatefor and/or isolate hose drag (i.e., forces applied to the seal 500 by aconduit coupled to the inlet orifice 130) and/or can advantageouslyallow for adaptation to differing facial geometry of different users. Inuse, the lower bellows portion 520, e.g., the bellows structure 522, isconfigured to be in a compressed state when the seal 500 is fitted tothe user's face. Therefore, if hose drag occurs, the lower bellowsportion 520 expands away from the user's face before the sealingsurfaces 512 and/or prongs 120, 121 are pulled away from the user'sface, which can cause or allow for leaks between the seal 500 and user'sface. A greater range of possible compression and extension of the lowerbellows portion 520 allows the seal 500 to withstand a greater degree ofhose drag. In some embodiments, an initial (i.e., in a relaxed state inwhich the seal 500 has not been expanded, compressed, splayed, orinflated as described herein) height of the seal 500 (indicated by h1 inFIG. 34) is 32 mm. In some embodiments, when the seal 500 is fully ormaximally compressed, a connector coupled to the inlet orifice 130 canbe displaced (where the amount of displacement is indicated by h2 inFIG. 34) relative to the sealing surface 512 by up to 12 mm withoutadversely affecting the performance of the sealing surface 512.

The bellows structure 522 may be any suitable bellows arrangement thatpermits relative movement between the base and the prongs 120, 121, suchas the movement described immediately above or elsewhere herein. Forexample, the bellows structure 522 may be a structure of reduced crosssectional area or, alternatively, may be a thinner section on the innerside of the wall, or a combination thereof. The bellows section may havea planar outer wall shape/structure (or a curved shape that iscontinuous with portions of the seal 500 outside of the bellows section)and may have an internal thinning of the wall to result in thesame/similar function as the bellows structure 522.

A further alternative arrangement is that the bellows section could be aconvex bellows rather than a concave section as shown. The currentillustrated embodiment shows a bellows section 522 or a pleat that isconcave in shape, but alternatively the bellows section 522 may be apleat that is convex and extends outwardly. In at least someconfigurations, the convex bellows would expand outwardly whencompressed. Such a convex bellows section can act as a support toprevent the seal from over rotating about the center of the bellows.

The sealing portion 210 can pivot around the center of the bellowsstructure 522 (for example, as indicated by the curved arrows in FIG.33) such that the sealing portion 210 can be angled relative to thelower bellows portion 520. Such pivoting can allow the seal 500 tocompensate for angled forces applied to the seal 500 by the conduitattached to the inlet orifice 130 and can help inhibit or reducedisturbance to the sealing surface 512 that may result from such angledforces. The pivoting can also allow the seal 500 to adjust for andaccommodate variability in the angle of the user's lower nasal surfacesfor different users.

In some embodiments, the center of the inlet orifice 130 and center ofthe sealing surface 512 are aligned or approximately aligned, asindicated by the horizontal arrows and dashed lines in FIG. 33. Suchalignment can advantageously encourage the bellows structure 522 tocompress rather than form a hinge about which the sealing portion 510and lower bellows portion 520 bend relative to each other. The forcesapplied to the inlet orifice 130 and the sealing surface 512 can beoffset, but oriented in the same direction or parallel to one another.In some configurations, the offset is small relative to a size of theseal 500, such as relative to a cross-sectional dimension of theconnector opening 130 or interior cavity of the seal 500.

As shown, the seal 500 can have a rounded cross-sectional profile. Inother words, the seal 500 may not have sharp corners. A roundedcross-sectional profile can advantageously promote a smooth compressionmotion of the seal 500 and a substantially linear increase in force asdisplacement or compression of the seal 500 increases during at least aportion of the range of compression, as shown in the force vs. extensiongraph of FIG. 35.

In the illustrated embodiment, the seal 500 has a relatively large inletorifice 130 in comparison with an overall size of the seal 500 (e.g.,cross-sectional dimension of the cavity or other portion of the seal500). A relatively large inlet orifice 130 can allow the seal 500 to beremoved from a mold tool more easily during manufacturing. As shown, aperimeter of the inlet orifice 130 is inwardly offset from an outerperimeter of the lower bellows portion 520. This offset is large enoughsuch that the inlet orifice 130 does not significantly interfere withthe function of the lower bellows portion 520 and bellows structure 522.

As shown by the generally horizontal arrow in FIG. 36, lateral sides ofthe lower bellows portion 520 can curve toward the sealing portion 510(upward in the orientation of FIG. 36). In the illustrated embodiment, acurvature of the lower bellows portion 520 matches or corresponds to (orsubstantially or generally matches or corresponds to) a curvature of thelower surfaces of the sealing portion 510. In such embodiments, adistance between the lower bellows portion 520 and the lower surfaces ofthe sealing portion 510 (indicated by the generally vertical arrows inFIG. 36) is substantially the same or equal around an entirecircumference of the seal 500. In some embodiments, the distance betweenthe lower bellows portion 520 and the lower surfaces of the sealingportion 510 is 6 mm. A constant distance between the lower bellowsportion 520 and lower surfaces of the sealing portion 510 around thecircumference of the seal 500 can advantageously allow for a more evencompression of the seal 500 around the entire lower bellows portion 520.In other words, the seal 500 is less likely to bottom out in one area ofthe seal 500 before a remainder of the circumference of the seal 500.The curvature of the lower bellows portion 520 can also give the seal500 a smaller appearance.

The perimeter of the lower bellows portion 520 and bellows structure 522can be smaller than the perimeter of the sealing portion 510 as shown inFIGS. 37-38. A relatively smaller lower bellows portion 520 canadvantageously help reduce or minimize the size of the seal 500. Asshown in FIG. 37, the lower bellows portion 520 can offset (indicated byarrow 523) from a back of the sealing portion 510 (e.g., from a lowest,in the orientation of FIG. 37, point of proximal wall 124). Such anoffset can inhibit the lower bellows portion 520 from contacting theuser's lip in use. In some embodiments, the sealing portion 510 has agreatest width (indicated by W4 in FIG. 38) of 43 mm, the inlet orifice130 has a width (indicated by W1 in FIG. 38) of 28 mm, the lower bellowsportion 520 has a greatest width (indicated by W2 in FIG. 38) of 34 mm,and the bellows structure 522 has a width (indicated by W3 in FIG. 38)of 26.5 mm. Such dimensions are exemplary and may vary. However, in someconfigurations, the relative sizes can be as illustrated.

In some embodiments, the sealing portion 510 and/or prongs 120, 121 canflex outwardly or away from each other as indicated by dashed linesshowing a flexed or splayed prong profile in FIG. 39. Flexing of theprongs 120, 121 or sealing portion 510 can advantageously allow the seal500 to accommodate users having relatively large nares and/or nares thatare spaced apart by a relatively wide septum. Reducing or minimizing aheight of a portion of the sealing portion 510 not including the prongs120, 121 (indicated by “h” in FIG. 39) advantageously allows for atight, continuously curved outer surface in the sealing portion 520,which can increase the ability of the prongs 120, 121 to splay outwardswithout the outer surfaces of the seal 500 collapsing as a shorter, morecurved surface is generally less likely to buckle and/or collapse. Insome embodiments, the height h is 19 mm. In some embodiments, the prongs120, 121 can splay outwardly away from each other by 2 mm or more. Insome embodiments, a distance between innermost edges of the prongs 120,121 in a relaxed state is 7.5 mm and a distance between the innermostedges of the prongs 120, 121 is a splayed state is 9.5 mm.

In some embodiments, the seal 500 is semi-inflatable. When the prongs120, 121 are engaged and sealed with the user's nares and CPAP pressureis applied in use, the seal 500 inflates slightly. The seal 500 canextend or increase in height (along a direction parallel to an axisextending through the center of the inlet orifice 130, indicated by thedashed lines in FIG. 33) and/or the prongs 120, 121 can splay apart fromeach other as shown by the inflated profile outline shown in FIG. 40.Such inflation can advantageously allow the prongs 120, 121 to engagethe user's nares more securely and improve the seal with the user'snares. In some embodiments, the seal 500 can increase in height by 2 mmor more when inflated. In some embodiments, the prongs 120, 121 cansplay apart from each other by 2 mm or more when the seal 500 isinflated.

In some embodiments, a thickness of the bellows structure 522 isconsistent or constant throughout the bellows structure 522. Thethickness of the bellows structure 522 can be 0.75 mm. In someembodiments a thickness of the lower bellows portion 520 is consistentor constant throughout the lower bellows portion 520. A constantthickness can advantageously provide unbiased compression over theentirety of the bellows structure 522 and/or lower bellows portion 520.In such an embodiment, the cross-sectional profile of the seal 500 wouldtherefore have a more significant impact on how compression of the seal500 occurs than the thickness of the seal 500.

In some embodiments, the seal 500 includes a thickened region 530 asshown in FIG. 41 that has a greater cross-sectional thickness than aremainder of the seal 500. In the illustrated embodiment, the thickenedregion 530 extends along lateral front portions of the seal 500. Thethickened region 530 can help prevent or inhibit the sealing surface 512from collapsing in the thickened region 530. In some embodiments, thethickened region 530 has a thickness of 1 mm and a remainder of the seal500 has a thickness of 0.75 mm or similar relative thicknesses.

Alternatively, the bellows section may have a varying thickness. Thebase section of the bellows may be thickest and the portion of thebellows at the top, i.e., closest to the prong or pillow is thinnest, orvice-versa. The thin portion of the bellow allows for greaterflexing/pivoting. The thicker base allows for greater stability at thebase.

In a further alternative, the bellow may be thick at the base and at thetop and thin in the middle. The middle being thinner than the top andthe bottom of the bellow. This allows for greater flexibility andflexure in the middle section of the bellow, while the thicker sectionprovide for greater support at the top and bottom of the seal, allowingthe prong to maintain its shape and also maintain orientation.

In some embodiments, an inner volume of the lower bellows portion 520,indicated by area 3 in FIG. 42I, is about 3966 mm3. In some embodiments,an inner volume of sealing portion 510 is about 11,158 mm3. An innervolume of each half of the sealing portion 510 (indicated by areas 1 and2 in FIG. 42I where the sealing portion 510 is separated by a planeextending between the prongs 120, 121) can be 5579 mm3. Thus, the areas1 and 2 can be collectively greater than the volume 3. In someconfigurations, each of the volumes 1 and 2 can be greater than thevolume 3.

Seal with Rolling Section

FIGS. 43-54C illustrate an example embodiment of a seal 600 thatincludes a rolling section 620 between the sealing surface 610 and aconnector receiving portion 630. The rolling section 620 canadvantageously at least partially isolate the sealing surface 610 fromhose drag forces. The rolling section 620 and sealing surface 610 aredelimited or separated by a stiffener or stiffening member, such as arib 640, that projects inwardly from an inner surface of the seal 600.The rolling section 620 is configured to roll over the connectorreceiving portion 630, as indicated by the dashed line profile in FIG.44, to absorb or accommodate for forces on the connector receivingportion 630 and inhibit deformation of the sealing surface 610. In someembodiments, a height of the seal 600 in a neutral state, indicated byh1 in FIG. 44, is 34.5 mm. In some embodiments, a height of the seal 600can decrease by approximately 5 mm or more when the rolling section 620is rolled over the connector receiving portion 630. In some embodiments,the height of the seal 600 in a compressed state in which the rollingsection 620 is rolled over the connector receiving portion 630,indicated by h2 in FIG. 44, is approximately 29.9 mm. In otherconfigurations, the height may differ from that described above, but therelative amount of roll can remain the same.

The rib 640 can advantageously separate the rolling section 620 from thesealing surface 610 to help isolate movement of the connector receivingportion 630 from the sealing surface 610 and reduce or minimize theeffect of hose drag. The rib 640 and/or rolling section 620 can alsoadvantageously allow the sealing surface 610 to be positioned atdiffering angles relative to the connector receiving portion 630 suchthat the seal 600 can adapt to and accommodate varying facial geometriesof different users. In some embodiments, the rib 640 is positionedapproximately halfway between the sealing surface 610 (e.g., a portionof the sealing surface 610 between the prongs 120, 121) and theconnector receiving portion 630.

The rib 640 can extend around an entire inner perimeter of the seal 600.In other embodiments, the rib 640 includes a gap 642 extending along atleast a portion of the front of the seal 600 as shown in FIGS. 43-44.Once the rolling section 620 rolls over the connector receiving portion630 to a certain extent, the rib 640 contacts internal surfaces of therolling section 620 and/or the connector receiving portion 630 toprevent or inhibit further movement. In embodiments in which the rib 640includes a gap 642 along the front of the seal 600, the gap allows therolling section 620 in the front of the seal 600 to roll farther overthe connector receiving portion 630 than the back of the seal 600. Thisallows for a greater travel or range of motion of the rolling portion620 in the front of the seal 600 and the rolling section 620 in thefront of the seal 600 may therefore not bottom out.

In some embodiments, the seal 600 is configured to be fitted to the userin use such that the rolling section 620 is at least partially rolledover the connector receiving portion 630 at least a majority of thetime. This advantageously allows the connector receiving portion 630 tobe pulled away from the sealing surface 610 to some extent without thesealing surface 610 losing contact with the user's nares.

In some embodiments, the rib 640 is made of silicone. In someembodiments, the rib 640 has an inner thickness (indicated by dimensionY in FIG. 45) in the range of 1 mm-4 mm, for example, 1.7 mm, an outerthickness (indicated by dimension Z in FIG. 45) in the range of 1 mm-5mm, for example, 2.5 mm, and a length (indicated by dimension X in FIG.45) in the range of 1 mm-6 mm, for example, 3 mm. The inner thicknesscan be less than the outer thickness. The length can be greater than theinner and outer thicknesses. In some embodiments, the rib 640 hasrounded edges.

A thickness of the rolling section 620 can gradually transition betweenthe rib 640 and the connector receiving portion 630 as shown in FIG. 46.For example, in some embodiments, the thickness transitions from 0.5 mmproximate or adjacent the connector receiving portion 630 to 0.8 mmproximate or adjacent the rib 640. In other configurations, the actualdimension may differ, but the proportions can be the same. Thetransitioning thickness advantageously allows the rolling section 620 tohave a spring force that increases as the seal 600 becomes morecompressed, which can help prevent or inhibit sharp increases in forcethat may be caused by the seal 600 suddenly bottoming out. This canadvantageously improve user comfort. The force on the seal 600 increasessubstantially linearly as the rolling section 620 is displaced andremains relatively low until the rolling section 620 bottoms out, forexample as shown in the theoretical force vs. displacement profile shownin FIG. 47 and force profile shown in FIG. 48. The thickness of the seal600 can be consistent or constant throughout the sealing surface 610. Insome embodiments, the thickness of the sealing surface 610 is 0.75 mm.FIG. 49 shows a heat map showing the generally constant thickness in thesealing surface 610 and varying thickness at the rib 640, rollingsection 620, and connector receiving portion 630.

In some embodiments, the connector receiving portion 630 is generallykidney bean shaped and follows the overall shape of the seal 600 asshown in FIGS. 50A-50C. In such embodiments, the rolling section 620extends outwardly from the connector receiving portion 630 asubstantially or relatively more uniform depth or distance (indicated bythe arrows in FIG. 50A as well as D1 and D2 in FIG. 51) around theentire perimeter or circumference of the seal 600. In contrast, if theconnector receiving portion 630 had a generally oval shape, indicated bythe dashed line in FIG. 50B, the rolling section 620 would have anuneven depth or distance as indicated by the arrows in FIG. 50B. Arelatively more uniform depth of the rolling section 620, as provided bythe kidney bean shaped connector receiving portion 630, advantageouslyallows the seal 600, e.g., the rolling section 620, to roll more evenlyacross the entire lower half of the seal 600 or around an entireperimeter or circumference of the seal 600.

In some embodiments, the prongs 120, 121 can splay apart from each otherto accommodate varying septum widths of different users as shown in FIG.52. The rolling section 620 advantageously allows the prongs 120, 121 tosplay apart without the sealing surfaces 610 collapsing or collapsing toa significant extent.

The connector receiving portion 630 extends from an intersection 634with the rolling section 620 to an open base end 632 configured toreceive, for example, a conduit or connector. In the illustratedembodiment, the open base end 632 and intersection 634 with the rollingsection 620 are curved. The curvature of the intersection 634 canencourage consistent movement of the rolling section 620 around theperimeter or circumference of the seal 600. The curvature of theintersection 634 and/or base end 632 can also make the seal 600 shorterand/or give the seal 600 a relatively smaller appearance compared to aseal having a flat or straight intersection and/or base end. In someembodiments, the curvature is such that a distance (indicated by h1 inFIG. 53A) between a center of the base end 632 or intersection 634 and alateral side of the base end 632 or intersection 634, respectively,along a line parallel to an axis extending through the center of theconnector receiving portion 630 and between the prongs 120, 121 isapproximately 3.26 mm.

Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise”, “comprising”, and thelike, are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense, that is to say, in the sense of“including, but not limited to”.

Reference to any prior art in this specification is not, and should notbe taken as, an acknowledgement or any form of suggestion that thatprior art forms part of the common general knowledge in the field ofendeavor in any country in the world.

The disclosure may also be said broadly to consist in the parts,elements and features referred to or indicated in the specification ofthe application, individually or collectively, in any or allcombinations of two or more of said parts, elements or features.

Where, in the foregoing description reference has been made to integersor components having known equivalents thereof, those integers areherein incorporated as if individually set forth.

It should be noted that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications may be madewithout departing from the spirit and scope of the inventions andwithout diminishing its attendant advantages. For instance, variouscomponents may be repositioned as desired. It is therefore intended thatsuch changes and modifications be included within the scope of theinventions. Moreover, not all of the features, aspects and advantagesare necessarily required to practice the present inventions.Accordingly, the scope of some of the present inventions is intended tobe defined only by the claims that follow.

1. (canceled)
 2. A nasal seal comprising: a seal body formed of a soft flexible material and defining an inner cavity and a supply opening for supply of breathing gases to the inner cavity, the seal body comprising: a first nostril prong; a second nostril prong; a rolling section disposed in a sidewall portion of the seal body, the rolling section being located between the supply opening and the first nostril prong and the second nostril prong, wherein the rolling section is configured to roll over on itself to reduce a distance between the supply opening and the first nostril prong and second nostril prong.
 3. The nasal seal of claim 2, wherein the rolling section further comprises a rib that extends in a circumferential direction of the seal body.
 4. The nasal seal of claim 3, wherein the rib is configured to contact an interior surface of the seal body to limit the roll of the rolling section and maintain the first nostril prong and the second nostril prong in an operational position.
 5. The nasal seal of claim 3, wherein the rib extends only partially around a circumference of the seal body.
 6. The nasal seal of claims 3, wherein the rib defines a gap in the front of the seal body.
 7. The nasal seal of claim 6, wherein the gap allows the rolling section in the front of the seal body to roll further towards or over the supply opening than the back of the seal.
 8. The nasal seal claim 3, wherein the rib is disposed between the supply opening and the first nostril prong and second nostril prong and projects inwardly or outwardly from the sidewall portion.
 9. The nasal seal of claim 3, wherein the rib is positioned halfway between sealing surfaces of the first nostril prong and second nostril prong and the supply opening.
 10. The nasal seal of claim 3, wherein a thickness of the rolling section gradually varies between the rib and the supply opening, the rolling portion being thicker adjacent the rib and thinner adjacent the supply opening.
 11. The nasal seal of claim 3, wherein the rib is cantilevered from the sidewall portion, the rib tapering in thickness between a thicker portion adjacent the sidewall portion and a thinner portion further from the sidewall portion.
 12. The nasal seal of claim 3, wherein the rib has an inner thickness in the range of 1 mm-4 mm and an outer thickness in the range of 1 mm-5 mm.
 13. The nasal seal of claim 3, wherein the rib has a length in the range of 1 mm-6 mm.
 14. The nasal seal of claim 2, wherein the supply opening is kidney bean shaped and generally follows the overall shape of the seal body.
 15. The nasal seal of claim 2, wherein an intersection between the rolling section and an end of the seal body that defines the supply opening is curved in a lateral direction of the nasal seal.
 16. The nasal seal of claim 2, wherein the first and second nostril prongs can splay apart from each other to accommodate varying septum widths. 